FDA Drops New Bioequivalence Guides: Generic Drugs Get Study Tips
Published Date: 8/24/2026
Notice
Summary
The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The draft guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry titled "Bioequivalence Recommendations for Specific Products" that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The draft guidances identified in this notice were developed using the process described in that guidance.
Analyzed Economic Effects
3 provisions identified: 1 benefits, 0 costs, 2 mixed.
New Draft BE Guidances Posted
FDA posted new draft product-specific guidances that give recommendations for designing bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for listed active ingredients. The new-draft list includes Avatrombopag maleate, Benzoyl peroxide, Bimatoprost, Bosutinib monohydrate, Epinephrine, Lisdexamfetamine dimesylate, Meloxicam, Mitomycin, Nimodipine, and others shown in Table 1. FDA is accepting comments on these draft guidances and you should submit comments by October 23, 2026 if you want the Agency to consider them before it begins work on the final versions.
Revised Draft BE Guidances Posted
FDA posted revised draft product-specific guidances that update recommendations for designing bioequivalence (BE) studies to support ANDAs for another set of active ingredients. The revised-draft list includes Amphetamine, Baricitinib, Buprenorphine, Levothyroxine sodium, Ondansetron, Zolpidem tartrate, and others shown in Table 2. Comments on these revised drafts should also be submitted by October 23, 2026 to ensure consideration before FDA begins work on final guidances.
Agency Will Weigh Cost Comments
FDA stated it will consider comments on costs or cost savings that the guidances may generate as it develops final guidance, consistent with Executive Order 14192. To have those comments considered before FDA begins final guidance work, submit them by October 23, 2026.
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